510(k) Report

Devices descending from K030527

856 later devices reach Lumenis Family of Ipl and Combination Ipl/ND:Yag Systems through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K250189AdvaTxAdvalight Aps20250—
+5K241791Medical Diode Laser Systems (GBOX-6H, GBOX-10D , GBOX-12D, GBOX-15D, VELAS Pro-30B15D…Gigaalaser Company, Ltd.20251—
+5K234004Medical diode laser systems (CHARISMA, REGAL)Reveal Lasers, Ltd.20251—
+5K243037Diode Laser System model Dawn-SShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20240—
+5K241092Youlaser PRIME; Youlaser PRIME CO2; Youlaser PRIME MTQuanta System Spa20240—
+5K241771Liftendo; Liftendo 2.0Medical San Indústria DE Equipamentos Médicos Ltda.20240—
+5K233803UltraClear Laser System (N/A)Acclaro Corporation20241—
+5K240179Medical Diode Laser (Model: L2)Wuhan Pioon Technology Co., Ltd.20242—
+5K233143PiXel8-RevealRohrer Aesthetics20240—
+5K233550MOSAIC 3D (Surgical Laser)Lutronic Aesthetic20240—
+5K231394Intense Pulsed Light SystemSmedtrum Medical Technology Co., Ltd.20232—
+5K230077LaserMENeauvia North America20232—
+5K222790F65 Laser SystemLumenis Be, Ltd.20233—
+5K230274Medical Diode Laser (M2)Wuhan Pioon Technology Co., Ltd.20232—
+5K221623FlexSys, FlexSys UVB EPL 308 nm, FlexSys UVB EPL lite 308 nm, FlexSys IR 1550 nmGme German Medical Engineering GmbH20230—
+5K222221Deka HelixEl.En Electronic Engineering Spa20231—
+5K223647CLEAR+BRILLIANT TOUCH® Laser SystemSolta Medical, Inc.20220—
+5K221268SR-1 Skin Treatment SystemAVAVA, Inc.20223—
+5K222800Diode Laser Hair Removal Systems for Medical Use (Models: Milestone Smart-M, Milestone…Sanhe Laserconn Tech Co., Ltd.20220—
+5K221770Fiber Laser Treatment SystemShanghai Apolo Medical Technology Co., Ltd.20221—
+5K221712Fotona XPulse Laser System Family (XPulse 1064 nm, XPulse 810 nm, XPulse 980 nm)Fotona D.O.O.20221—
+5K213332Multifrax Laser SystemParadigm Medical Corporation20220—
+5K210183Waterlase iPLusBiolase, Inc.20220—
+5K212492Frax 1940 for Nordlys and Frax ProCandela Corporation20210—
+5K210847UltraClear Fractional Laser SystemFa International, LP20210—
+5K202288FinebeamSNJ Co., Ltd.20212—
+5K212607DarwinLuvo Medical Technologies, Inc.20210—
+5K201520The Alma Opus System, Colibri Applicator and TipsAlma Lasers, Inc.20211—
+5K212270DEKA LipoAIEl.En Electronic Engineering Spa20210—
+5K202991Fotona XPulse Pro Laser PlatformFotona D.O.O.20213—
+5K202955Contour Light CL-100Contour Research, LLC20218—
+5K203299CellFX SystemPulse Biosciences, Inc.20214—
+5K201064V30 System, V20 System, V10 System, V-FR HandpieceViora, Ltd.20200—
+5K200104OxylightRaja Trading Company, Inc.202024—
+5K192951Ellipse Frax 1940 for Ellipse Nordlys and Ellipse YdunEllipse A/S20201—
+5K193367elysion-proHigh Technology Products S.L.U20203—
+5K193446Bare: 808Luvo Medical Technologies, Inc.20202—
+5K192755Soli-Lite LG4 GalileoSilhouet-Tone Corporation20193—
+5K192521Intense Pulsed Light Treatment SystemShangdong Huamei Technology Co., Ltd.20193—
+5K192331LaseMD LEO Laser SystemLutronic Global20190—
+5K191942MT One DiamondM&T S.R.L.20191—
+5K191321Primelase ExcellenceHigh Technology Products S.L.U20198—
+5K182173Joule SystemSciton, Inc20195—
+5K180359BTL-FR2000BTL Industries, Inc.20189—
+5K181868SHINY RPL SystemIds, Ltd.20181—
+5K172193Modified Alma Lasers Soprano XL™ Family ofMulti-Application & Multi-Technology Platforms…Alma Lasers, Inc.201822—
+5K1730022940 nm Er:Yag Laser HandpieceQuanta System Spa20171—
+5K170187Photodynamic Therapy DeviceUvbiotek, LLC20170—
+5K163137NIRA Beauty Skin LaserDermal Photonics Corporation20171—
+5K171009LASEMD Laser SystemLutronic Corporation20178—
+5K162556Lightfusion Led SystemVitage Led, Ltd.20170—
+5K162098LED Phototherapy DeviceLi-Tek Electronic Technology Corporation201775—
+5K162363V30 system, V-Form Handpiece BC Medium applicatorViora, Ltd.20163—
+5K161162Frax 1550 for Ellipse Nordlys/ Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity…Ellipse A/S20164—
+5K160075Accent XLAlma Lasers, Inc.20160—
+5K161286IPL Therapy MachineBeijing Adss Development Co., Ltd.20165—
+5K152280BioPhotas Celluma3Biophotas, Inc.201649—
+5K152153MicroSpot HandpieceAsclepion Laser Technologies GmbH20156—
+5K152722neoV980 & neoV1470 Diode LasersG.N.S Neolaser, Ltd.201517—
+5K151655CO2RE SystemSyneron Medical, Ltd.20151—
+5K150161Venus Viva SR DeviceVenus Concept, Ltd.20159—
+5K143723SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP SpectroFotona D.D.201562—
+5K150051ExiliteBTL Industries, Inc.20150—
+5K143519The MeDioStar NeXT FamilyAsclepion Laser Technologies GmbH201532—
+5K140668Platinumgmt Ipl System CloudGlobal Medical Technology S.L.20142—
+5K141507Two Skin Treatment SystemSyneron Medical, Ltd.20140—
+5K142093V20 SystemViora, Ltd.201432—
+5K140727Cutera Picosecond Laser SystemCutera, Inc.201447—
+5K133945Cutera Picosecond Laser SystemCutera, Inc.201414—
+5K133364Picosure WorkstationCynosure, Inc.201451—
+5K133774AtovenBio-Med USA, Inc.20146—
+5K131712A-Tone Ipl SystemYbk Investment, Inc.20140—
+5K130501IntensifEndymed Medical, Ltd.201457—
+5K133254Revlite Q-Switched ND:Yag Laser SystemCynosure, Inc.201457—
+5K131837CO2 Fractional LaserBeijing Honkon Technologies Co., Ltd.20140—
+5K131113Biophotas CellumaBiophotas, Inc.201455—
+5K131758Surgen UPollogen, Ltd.20135—
+5K131095Deka Synchro Repla: Y Family of Laser SystemsEl.En Electronic Engineering Spa201317—
+5K130793Newa Skin Therapy SystemEndymion Medical, Ltd.20130—
+5K123573Youlaser CO2 LaserQuanta System Spa201319—
+5K113504Deka Smartxide and Delivery AccessoriesEl.En Electronic Engineering Spa201312—
+5K121346Picosure WorkstationCynosure, Inc.201287—
+5K120513Glow by EndymedEndymed Medical, Ltd.20125—
+5K110333Naturalase CO2 Laser SystemFocus Medical, LLC20121—
+5K120433Clear + Brilliant Laser SystemSolta Medical, Inc.20121—
+5K110375Blueshine's Gold SeriesBlueshine Srl20124—
+5K112013Evolve (R) HPD 980/1470NM Multiwavelength Diode LaserBiolitec, Inc.20126—
+5K110672Etwo Skin Treatment SystemSyneron, Ltd.20112—
+5K110907Palomar Icon (TM) Aesthetic SystemPalomar Medical Technologies, Inc.201157—
+5K103664Primus Aesthetic PlatformPalomar Medical Technologies, Inc.20117—
+5K110080Radial-Emitting Shaped Fiber Optic Delivery SystemBiolitec, Inc.201126—
+5K102755Ceralas E/ 1470NM Fiber-Coupled Diode Laser Family; Crealas HPD Multiwavelenght 980NM/…Biolitec, Inc.201046—
+5K102036Doctor Surgery Diode Lasers FamilyLambda S.P.A.20107—
+5K100143Pilot Diode Laser, Model 002-00139CAO Group, Inc.201020—
+5K100558Quanta Diode Laser SystemQuanta System Spa201068—
+5K091664GSD Intense Pulsed Light System, Models: GP666C4, GP666CShenzhen Gsd Tech Co., Ltd.20094—
+5K091115ECO2 Laser SystemLutronic Corporation200927—
+5K090639EXELO2, Model 4010Quantel Derma GmbH20090—
+5K090762LEDAQuantel Derma GmbH200946—
+5K083730IsolazAesthera Corporation20093—